Trial Outcomes & Findings for 3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy (NCT NCT01751451)
NCT ID: NCT01751451
Last Updated: 2021-11-19
Results Overview
defined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (\>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
124 participants
Primary outcome timeframe
18 months
Results posted on
2021-11-19
Participant Flow
Participant milestones
| Measure |
Abiraterone Acetate
Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
|
Abiraterone Acetate and Degarelix
Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
|
Degarelix
Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months
Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
40
|
42
|
|
Overall Study
COMPLETED
|
42
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
3-arm Study of Abiraterone Acetate Alone, Abiraterone Acetate Plus Degarelix, a GnRH Antagonist, and Degarelix Alone for Patients With Prostate Cancer With a Rising PSA or a Rising PSA and Nodal Disease Following Definitive Radical Prostatectomy
Baseline characteristics by cohort
| Measure |
Abiraterone Acetate
n=42 Participants
Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
|
Abiraterone Acetate and Degarelix
n=40 Participants
Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
|
Degarelix
n=42 Participants
Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months
Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
|
Total
n=124 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.6 years
n=5 Participants
|
66.2 years
n=7 Participants
|
63.7 years
n=5 Participants
|
64.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
123 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
106 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 18 monthsdefined as an undetectable PSA (using a routine non-ultrasensitive PSA assay) with non-castrate level of testosterone (\>150 ng/dL) at 18 months from the time of treatment initiation (PSA0).
Outcome measures
| Measure |
Abiraterone Acetate
n=42 Participants
Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
|
Abiraterone Acetate and Degarelix
n=40 Participants
Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
|
Degarelix
n=42 Participants
Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months
Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
|
|---|---|---|---|
|
Progression-free Survival (PFS)
|
5.1 percentage change of PSA
Interval 1.0 to 17.0
|
17.1 percentage change of PSA
Interval 7.0 to 32.0
|
11.9 percentage change of PSA
Interval 4.0 to 26.0
|
PRIMARY outcome
Timeframe: 1 yearPopulation: N/A - data were not collected
In addition to an undetectable PSA, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (Complete Response per RECIST) in order to meet the criteria for PFS. Outcome in subjects who develop radiographically evident metastatic disease while on study will be considered treatment failures independent of their respective PSA values.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 monthsPopulation: N/A - data were not collected
The percentage of patients with a non-castrate level of testosterone (\>150 ng/dL) and an undetectable PSA at 8 months from PSA0 will be measured.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: N/A - data were not collected
with particular attention to libido, potency, anxiety, depression, hot flashes, and fatigue. Effects of each arm on health-related quality of life will be assessed via PRO Survey (Appendix C) completed on paper by the patient at the following study visits: Up to 30 Days Prior to Randomization, each Day 1 of Treatment Cycle, End of Treatment, and each Post-Treatment Follow-up.Effects of each arm on quality of life,
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: N/A - data were not collected
Safety will be evaluated according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, physical examinations and clinical laboratory tests throughout the conduct of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 -10 monthsPopulation: N/A - data were not collected
Testosterone and LH recovery rates will be measured at 8 months from the start of randomization and at each month of the 10 month follow up period.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: N/A - data were not collected
Tissue samples will be utilized for morphologic assessment, percent tumor involvement (if applicable), and immunohistochemistry. The immunohistochemical markers assessed may be AR, PTEN, PSMA, fatty acid synthase (FASN), phospho-AMPK, phospho-ACC, phospho-S6 kinase, phospho-Akt for the assessment of the AMPK, lipid synthesis, mTOR pathways, and immunological markers.
Outcome measures
Outcome data not reported
Adverse Events
Abiraterone Acetate
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Abiraterone Acetate and Degarelix
Serious events: 5 serious events
Other events: 5 other events
Deaths: 3 deaths
Degarelix
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abiraterone Acetate
n=42 participants at risk
Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
|
Abiraterone Acetate and Degarelix
n=40 participants at risk
Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
|
Degarelix
n=42 participants at risk
Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months
Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
|
|---|---|---|---|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
General disorders
Fever
|
4.8%
2/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Renal and urinary disorders
Hematuria
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Infections and infestations
Pelvic infection
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Infections and infestations
Sepsis
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Nervous system disorders
Stroke
|
0.00%
0/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Nervous system disorders
Syncope
|
0.00%
0/42 • 1 year
|
2.5%
1/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Renal and urinary disorders
Urinary tract obstruction
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
Other adverse events
| Measure |
Abiraterone Acetate
n=42 participants at risk
Group 1
* Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
Abiraterone acetate: Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
|
Abiraterone Acetate and Degarelix
n=40 participants at risk
Group 2
Abiraterone acetate 1000 mg daily x 8 months
* Prednisone 5 mg once daily x 8 months
* Degarelix subcutaneous depot injection q 1 month x 8 months
Abiraterone acetate plus degarelix: Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
|
Degarelix
n=42 participants at risk
Group 3
• Degarelix subcutaneous depot injection q 1 month x 8 months
Degarelix: Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
|
|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • 1 year
|
7.5%
3/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
2/42 • 1 year
|
0.00%
0/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Investigations
Blood bilirubin increased
|
4.8%
2/42 • 1 year
|
5.0%
2/40 • 1 year
|
0.00%
0/42 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
11.9%
5/42 • 1 year
|
5.0%
2/40 • 1 year
|
7.1%
3/42 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
4.8%
2/42 • 1 year
|
0.00%
0/40 • 1 year
|
2.4%
1/42 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/42 • 1 year
|
0.00%
0/40 • 1 year
|
7.1%
3/42 • 1 year
|
Additional Information
Dr. Howard Scher, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place